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AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

NCT05850234

RecruitingPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: Relapsed/Refractory Multiple Myeloma

Interventions: AZD0120

Countries: United States

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* ≥18 years of age at the time of consent.
* ECOG performance status of 0 or 1.
* Documented diagnosis of MM per IMWG diagnostic criteria.
* Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
* Have documented evidence of progressive disease per IMWG criteria.
* Participant must have measurable disease at screening.
* Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Exclusion Criteria :

* Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
* Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
* Participant has significant cardiac, neurological, or psychiatric conditions.
* Any other significant medical conditions such as:

  * Serious active or uncontrolled infection
  * Active autoimmune disease or a history of autoimmune disease within 2 years
  * Active plasma cell leukemia at the time of screening
  * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
* Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.
Locations (36)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • Omaha, Nebraska, United States
  • Hackensack, New Jersey, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Stony Brook, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • + 6 more on CT.gov